The New Flex Trial

FDA Approves First Telehealth Option to Program Cochlear Implants

The U.S. Food and Drug Administration today approved a remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform. The remote programming feature is indicated for patients who have had six months of experience with their cochlear implant sound processor and are comfortable with the programming process.

“Programming adjustments to a cochlear implant are performed at specialized cochlear implant centers or at clinics by audiologists with expertise in cochlear implants. Being able to have a qualified audiologist program the device via telemedicine from a remote location can greatly reduce the burden to patients and their families, especially those who must travel great distances or need frequent adjustments,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices in the FDA’s Center for Devices and Radiological Health.

A cochlear implant is an implanted electronic hearing device, designed to produce useful hearing sensations to a person with severe to profound hearing loss, by electrically stimulating nerves inside the inner ear. According to the National Institutes of Health, in the United States, roughly 58,000 cochlear implants have been implanted in adults and 38,000 in children, as of 2012.

Cochlear implants often require regular programming visits with an audiologist. During these visits, the audiologist adjusts various electronic settings that control how the implant stimulates the nerves inside the inner ear, such as adjustments in sensitivity to low-level sound or limits on loud sounds. This, in turn, changes how the patient perceives different sounds, such as speech or music in different environments. Generally speaking, these adjustments can improve the patient’s quality of life by improving their ability to understand speech, their comfort in loud environments or independence in performing daily tasks.

To support the approval of the remote programming feature for the Nucleus Cochlear Implant System, the FDA evaluated data from a clinical study of 39 patients, aged 12 or older, each of whom had a cochlear implant for at least one year. Each patient had one in-person programming session and two remote programming sessions, each approximately two months apart. Speech perception tests one month after each session showed no significant difference between in-person and remote programming. The FDA also evaluated data from patients’ self-assessment of their ability to hear speech in the presence of other sounds and sense the direction, distance and motion of sound. In addition, the FDA also assessed the cybersecurity measures for the remote interaction.

The FDA granted the approval of the Nucleus Cochlear Implant System to Cochlear Americas.